ID

42247

Beschrijving

Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS. https://clinicaltrials.gov/ct2/show/NCT00391872

Link

https://clinicaltrials.gov/ct2/show/NCT00391872

Trefwoorden

  1. 28-11-15 28-11-15 -
  2. 14-04-21 14-04-21 - Ahmed Rafee, MD
  3. 15-04-21 15-04-21 - Ahmed Rafee, MD
Houder van rechten

AstraZeneca

Geüploaded op

15 april 2021

DOI

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Licentie

Creative Commons BY 4.0

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Excerpt PLATO Acute coronary Syndrome NCT00391872

End of Treatment Visit

Visit
Beschrijving

Visit

Visit date
Beschrijving

Visit date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Clinical Events, Reminder
Beschrijving

Clinical Events, Reminder

Adverse event
Beschrijving

Adverse event

Datatype

boolean

Alias
UMLS CUI [1]
C0877248
Stroke/TIA
Beschrijving

Stroke/TIA

Datatype

boolean

Alias
UMLS CUI [1]
C0038454|C0007787
Other arterial thrombotic event
Beschrijving

Arterial thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0151942
Bleeding
Beschrijving

Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C0019080
Myocardial infarction
Beschrijving

Myocardial infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
Recurrent cardiac ischaemia/severe recurrent cardiac ischaemia
Beschrijving

Myocardial ischaemia

Datatype

boolean

Alias
UMLS CUI [1]
C0151744
Angina pectoris
Beschrijving

Angina pectoris

Datatype

text

Alias
UMLS CUI [1]
C0002962
Procedures, Reminder
Beschrijving

Procedures, Reminder

Has any procedure or operation been performed during the index event hospitalization
Beschrijving

Operation

Datatype

boolean

Alias
UMLS CUI [1]
C0543467
Coronary angiography
Beschrijving

Coronary angiography

Datatype

boolean

Alias
UMLS CUI [1]
C0085532
Percutaneous coronary revascularization
Beschrijving

Percutaneous coronary revascularization

Datatype

boolean

Alias
UMLS CUI [1]
C0877341
Cardiac surgery
Beschrijving

Cardiac surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0018821
Non-coronary revascularization
Beschrijving

Revascularization

Datatype

boolean

Alias
UMLS CUI [1]
C0581603
Other cardiovascular procedure
Beschrijving

Other cardiovascular procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0189573
UMLS CUI [1,2]
C0205394
CT or MRI imaging
Beschrijving

CT or MRI imaging

Datatype

boolean

Alias
UMLS CUI [1]
C0024485|C0040405
Non-cardiovascular invasive procedure
Beschrijving

Invasive procedure

Datatype

boolean

Alias
UMLS CUI [1]
C1548804
Stress test
Beschrijving

Stress test

Datatype

boolean

Alias
UMLS CUI [1]
C1384495
Echocardiography/radionuclide angiography
Beschrijving

Echocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0013516
Pacemaker
Beschrijving

Cardiac Pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
Intracardial defibrillator
Beschrijving

Intracardial defibrillator

Datatype

boolean

Alias
UMLS CUI [1]
C1273352
Intra-aortic balloon pump
Beschrijving

IABP

Datatype

boolean

Alias
UMLS CUI [1]
C0021860
Left ventricular assist device
Beschrijving

Left ventricular assist device

Datatype

boolean

Alias
UMLS CUI [1]
C0181598
Electrophysiology study
Beschrijving

Electrophysiology study

Datatype

boolean

Alias
UMLS CUI [1]
C1446476
Unplanned Holter monitoring
Beschrijving

Holter monitoring

Datatype

boolean

Alias
UMLS CUI [1]
C0013801
Swan Ganz catheter
Beschrijving

Swan Ganz catheter

Datatype

boolean

Alias
UMLS CUI [1]
C0007438
Ventilator
Beschrijving

Ventilator

Datatype

boolean

Alias
UMLS CUI [1]
C0087153
Ventilation/perfusion scan
Beschrijving

Ventilation/perfusion scan

Datatype

boolean

Alias
UMLS CUI [1]
C0560738
Pulmonary angiography
Beschrijving

Pulmonary angiography

Datatype

boolean

Alias
UMLS CUI [1]
C0677490
Other
Beschrijving

Other

Datatype

text

Alias
UMLS CUI [1]
C0205394
Has any transfusion been performed during the index event hospitalization
Beschrijving

Transfusion

Datatype

boolean

Alias
UMLS CUI [1]
C1879316
Has Subject been hospitalized since previous visit
Beschrijving

Hospitalization

Datatype

boolean

Alias
UMLS CUI [1]
C0019993
Overall Physical Examination
Beschrijving

Overall Physical Examination

Physical examination
Beschrijving

Physical examination

Datatype

text

Alias
UMLS CUI [1]
C0031809
Vital Signs, Weight
Beschrijving

Vital Signs, Weight

Blood pressure, supine
Beschrijving

Blood pressure

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Pregnancy Test
Beschrijving

Pregnancy Test

Assessment applicable for Subject
Beschrijving

For surgically sterile females, and post-menopausal females, select ‘No’.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0220825
Sampling date
Beschrijving

Pregnancy test date

Datatype

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test, urine
Beschrijving

Pregnant

Datatype

boolean

Alias
UMLS CUI [1]
C0549206
Electrocardiogram
Beschrijving

Electrocardiogram

Date of ECG
Beschrijving

Date of ECG

Datatype

date

Alias
UMLS CUI [1]
C2826640
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
New or presumed new Q waves since admission
Beschrijving

Q waves

Datatype

boolean

Alias
UMLS CUI [1]
C1305738
Any symptoms since previous visit that could explain the new or presumed new Q waves
Beschrijving

Q wave symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0429090
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C1457887
NYHA - Heart Failure
Beschrijving

NYHA - Heart Failure

Functional status according to New York Heart Association (NYHA) - modified
Beschrijving

NYHA class

Datatype

text

Alias
UMLS CUI [1]
C1275491
EQ-5D Health-Related Quality of Life Questionnaire
Beschrijving

EQ-5D Health-Related Quality of Life Questionnaire

Mobility
Beschrijving

Mobility

Datatype

text

Alias
UMLS CUI [1]
C3639375
Self-care
Beschrijving

Self-care

Datatype

text

Alias
UMLS CUI [1]
C3639376
Usual activities
Beschrijving

Usual activities

Datatype

text

Alias
UMLS CUI [1]
C3639377
Pain/discomfort
Beschrijving

Pain/discomfort

Datatype

text

Alias
UMLS CUI [1]
C3639378
Anxiety/depression
Beschrijving

Anxiety/depression

Datatype

text

Alias
UMLS CUI [1]
C3639379
Transition Antiplatelet Treatment
Beschrijving

Transition Antiplatelet Treatment

Subject will continue on ASA
Beschrijving

Aspirin

Datatype

boolean

Alias
UMLS CUI [1]
C0004057
Aspirin dose
Beschrijving

If Yes, dose

Datatype

integer

Maateenheden
  • mg
Alias
UMLS CUI [1,1]
C0004057
UMLS CUI [1,2]
C0178602
mg
Subject will continue on open clopidogrel (75 mg od)
Beschrijving

Clopidogrel

Datatype

boolean

Alias
UMLS CUI [1]
C0070166
If Yes, will Subject receive a transition loading dose
Beschrijving

Clopidogrel loading dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0070166
UMLS CUI [1,2]
C0178602
Subject will continue on other antiplatelet agent
Beschrijving

Antiplatelet therapy

Datatype

text

Alias
UMLS CUI [1]
C1096021

Similar models

End of Treatment Visit

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Visit
Visit date
Item
Visit date
date
C1320303 (UMLS CUI [1])
Item Group
Clinical Events, Reminder
Adverse event
Item
Adverse event
boolean
C0877248 (UMLS CUI [1])
Stroke/TIA
Item
Stroke/TIA
boolean
C0038454|C0007787 (UMLS CUI [1])
Arterial thrombosis
Item
Other arterial thrombotic event
boolean
C0151942 (UMLS CUI [1])
Hemorrhage
Item
Bleeding
boolean
C0019080 (UMLS CUI [1])
Myocardial infarction
Item
Myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Myocardial ischaemia
Item
Recurrent cardiac ischaemia/severe recurrent cardiac ischaemia
boolean
C0151744 (UMLS CUI [1])
Item
Angina pectoris
text
C0002962 (UMLS CUI [1])
Code List
Angina pectoris
CL Item
I. Ordinary physical activity does not cause angina (I. Ordinary physical activity does not cause angina)
I (UMLS CUI-1)
CL Item
II. Slight limitation of ordinary activity (II. Slight limitation of ordinary activity)
I (UMLS CUI-1)
CL Item
III. Marked limitation of ordinary activity (III. Marked limitation of ordinary activity)
I (UMLS CUI-1)
CL Item
IV. Inability to carry out any physical activity without discomfort - angina syndrome may be present at rest (IV. Inability to carry out any physical activity without discomfort - angina syndrome may be present at rest)
I (UMLS CUI-1)
Item Group
Procedures, Reminder
Operation
Item
Has any procedure or operation been performed during the index event hospitalization
boolean
C0543467 (UMLS CUI [1])
Coronary angiography
Item
Coronary angiography
boolean
C0085532 (UMLS CUI [1])
Percutaneous coronary revascularization
Item
Percutaneous coronary revascularization
boolean
C0877341 (UMLS CUI [1])
Cardiac surgery
Item
Cardiac surgery
boolean
C0018821 (UMLS CUI [1])
Revascularization
Item
Non-coronary revascularization
boolean
C0581603 (UMLS CUI [1])
Other cardiovascular procedure
Item
Other cardiovascular procedure
boolean
C0189573 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
CT or MRI imaging
Item
CT or MRI imaging
boolean
C0024485|C0040405 (UMLS CUI [1])
Invasive procedure
Item
Non-cardiovascular invasive procedure
boolean
C1548804 (UMLS CUI [1])
Stress test
Item
Stress test
boolean
C1384495 (UMLS CUI [1])
Echocardiography
Item
Echocardiography/radionuclide angiography
boolean
C0013516 (UMLS CUI [1])
Cardiac Pacemaker
Item
Pacemaker
boolean
C0030163 (UMLS CUI [1])
Intracardial defibrillator
Item
Intracardial defibrillator
boolean
C1273352 (UMLS CUI [1])
IABP
Item
Intra-aortic balloon pump
boolean
C0021860 (UMLS CUI [1])
Left ventricular assist device
Item
Left ventricular assist device
boolean
C0181598 (UMLS CUI [1])
Electrophysiology study
Item
Electrophysiology study
boolean
C1446476 (UMLS CUI [1])
Holter monitoring
Item
Unplanned Holter monitoring
boolean
C0013801 (UMLS CUI [1])
Swan Ganz catheter
Item
Swan Ganz catheter
boolean
C0007438 (UMLS CUI [1])
Ventilator
Item
Ventilator
boolean
C0087153 (UMLS CUI [1])
Ventilation/perfusion scan
Item
Ventilation/perfusion scan
boolean
C0560738 (UMLS CUI [1])
Pulmonary angiography
Item
Pulmonary angiography
boolean
C0677490 (UMLS CUI [1])
Other
Item
Other
text
C0205394 (UMLS CUI [1])
Transfusion
Item
Has any transfusion been performed during the index event hospitalization
boolean
C1879316 (UMLS CUI [1])
Hospitalization
Item
Has Subject been hospitalized since previous visit
boolean
C0019993 (UMLS CUI [1])
Item Group
Overall Physical Examination
Item
Physical examination
text
C0031809 (UMLS CUI [1])
Code List
Physical examination
CL Item
Normal (1)
I (UMLS CUI-1)
CL Item
Abnormal (2)
I (UMLS CUI-1)
CL Item
Not done (3)
I (UMLS CUI-1)
Item Group
Vital Signs, Weight
Blood pressure
Item
Blood pressure, supine
integer
C0005823 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Pregnancy Test
Assessment applicable for Subject
Item
Assessment applicable for Subject
boolean
C0681850 (UMLS CUI [1,1])
C0220825 (UMLS CUI [1,2])
Pregnancy test date
Item
Sampling date
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pregnant
Item
Pregnancy test, urine
boolean
C0549206 (UMLS CUI [1])
Item Group
Electrocardiogram
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Q waves
Item
New or presumed new Q waves since admission
boolean
C1305738 (UMLS CUI [1])
Q wave symptoms
Item
Any symptoms since previous visit that could explain the new or presumed new Q waves
boolean
C0429090 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item Group
NYHA - Heart Failure
Item
Functional status according to New York Heart Association (NYHA) - modified
text
C1275491 (UMLS CUI [1])
Code List
Functional status according to New York Heart Association (NYHA) - modified
CL Item
No limitation of physical activity: ordinary physical exercise does not cause undue fatigue, palpitations or dyspnoea  (I)
CL Item
Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations or dyspnoea (II)
CL Item
Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms (III)
CL Item
Unable to carry out any physical activity without discomfort: symptoms of congestive heart failure (CHF) are present even at rest with increased discomfort with any physical activity (IV)
Item Group
EQ-5D Health-Related Quality of Life Questionnaire
Item
Mobility
text
C3639375 (UMLS CUI [1])
Code List
Mobility
CL Item
I have no problems in walking about (1)
I (UMLS CUI-1)
CL Item
I have some problems in walking about (2)
I (UMLS CUI-1)
CL Item
I am confined to bed3 (3)
I (UMLS CUI-1)
CL Item
Missing/multiple responses (4)
I (UMLS CUI-1)
Item
Self-care
text
C3639376 (UMLS CUI [1])
Code List
Self-care
CL Item
I have no problems with self-care (1)
I (UMLS CUI-1)
CL Item
I have some problems washing or dressing myself (2)
I (UMLS CUI-1)
CL Item
I am unable to wash or dress myself (3)
I (UMLS CUI-1)
CL Item
Missing/multiple responses (4)
I (UMLS CUI-1)
Item
Usual activities
text
C3639377 (UMLS CUI [1])
Code List
Usual activities
CL Item
I have no problems with performing my usual activities (1)
I (UMLS CUI-1)
CL Item
I have some problems with performing my usual activities (2)
I (UMLS CUI-1)
CL Item
I am unable to perform my usual activities (3)
I (UMLS CUI-1)
CL Item
Missing/multiple responses (4)
I (UMLS CUI-1)
Item
Pain/discomfort
text
C3639378 (UMLS CUI [1])
Code List
Pain/discomfort
CL Item
I have no pain or discomfort (1)
I (UMLS CUI-1)
CL Item
I have moderate pain or discomfort (2)
I (UMLS CUI-1)
CL Item
I have extreme pain or discomfort (3)
I (UMLS CUI-1)
CL Item
Missing/multiple responses (4)
I (UMLS CUI-1)
Item
Anxiety/depression
text
C3639379 (UMLS CUI [1])
Code List
Anxiety/depression
CL Item
I am not anxious or depressed (1)
I (UMLS CUI-1)
CL Item
I am moderately anxious or depressed (2)
I (UMLS CUI-1)
CL Item
I am extremely anxious or depressed (3)
I (UMLS CUI-1)
CL Item
Missing/multiple responses (4)
I (UMLS CUI-1)
Item Group
Transition Antiplatelet Treatment
Aspirin
Item
Subject will continue on ASA
boolean
C0004057 (UMLS CUI [1])
Aspirin dose
Item
integer
C0004057 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Clopidogrel
Item
Subject will continue on open clopidogrel (75 mg od)
boolean
C0070166 (UMLS CUI [1])
Clopidogrel loading dose
Item
If Yes, will Subject receive a transition loading dose
boolean
C0070166 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Subject will continue on other antiplatelet agent
text
C1096021 (UMLS CUI [1])
Code List
Subject will continue on other antiplatelet agent
CL Item
Ticlopidine (1)
C0040207 (UMLS CUI-1)
CL Item
Dipyridamole (2)
C0012582 (UMLS CUI-1)
CL Item
Other (3)
I (UMLS CUI-1)

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